Insights and Analysis
AI-washing – when AI hype becomes a litigation risk
Álvaro Abad
Senior Associate Global Regulatory
Languages
English, Spanish
In recent years, Álvaro has actively led and participated in a broad range of regulatory and strategic matters in the pharmaceutical, biotech and medical devices sectors, developing an in-depth understanding of these industries and becoming a trusted partner for companies navigating complex regulatory frameworks and maximizing the value of their products and businesses. He also has significant experience in related regulated sectors, including controlled substances, food, cosmetics and technology products, and regularly supports Life Sciences-focused M&A transactions.
Álvaro is an active member of Hogan Lovells EU Life Sciences Regulatory team and works closely with colleagues worldwide, while maintaining a strong profile within the Spanish Life Sciences community. In addition, he has been a member of the Scientific Committee of the Dravet Syndrome Foundation for more than three years, collaborating with key opinion leaders in rare diseases and contributing his expertise in the market access of innovative medicinal products.
Álvaro has been recognized as an “Associate to Watch: Life Sciences” by Chambers & Partners, a “Leading Associate: Healthcare and Life Sciences” by Legal 500 and as a future star in Life Sciences in Spain by Expansión.
Advising leading pharmaceutical companies on clinical trials, including negotiation of clinical trial agreements, informed consent forms, patient claims, and post-trial access obligations.
Advising leading life sciences companies on market access strategies, including early access programs, off-label use, pricing and reimbursement matters, and interactions with the Spanish regulators.
Regulatory advice to pharma/biotech on approvals, post-authorisation, advanced therapies, discontinuations and shortages.
Advice on promotional compliance, HCP/HCO engagement, collaborations, campaigns and disputes before Farmaindustria/Autocontrol.
Advice on public procurement, including execution issues, penalties and procurement challenges.
Advice on alternative therapies, including psychedelics, on the legal framework and regulatory feasibility of projects/activities.
Advice to MedTech/digital health on compliance, CE marking, SaMD, telemedicine and digital health solutions.